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Oversight Challenges in Monitoring and Auditing: Exploring Biomedical Research

This article examines the challenges and limitations in oversight practices for monitoring and auditing biomedical research projects, particularly focusing on issues related to informed consent, feedback from research subjects, and management of adverse events.

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Oversight Challenges in Monitoring and Auditing: Exploring Biomedical Research

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  1. 2.2. Challenges and Limitations to Oversight Andres Soosaar, Estonia

  2. General positions • Monitoring and auditing are different activities: the audit is more legally estimated concept, monitoring is rather more flexible one with different practices • Regular (annual, quarterly) reporting of different aspects about projects is common practice; • Clinical trials and other biomedical research have quite different practices of oversight.

  3. Research subjects and REC • Very small feedback about problems in research projects from research subjects despite of possibility to do that; • Research subjects need to know contact information of the REC approved the project to inform about of misconduct of researchers.

  4. Informed consent issue • RECs have little information about the real informed consent process in reviewed projects, but there is not easy and efficient way to follow the consent procedure by REC • REC mainly trust researchers in realizing informed consent procedure after approval of the project • In case of high risk study REC could perform survey on limited group of participants how efficient has been the consent procedure or • Have RECs some internal list of most complicated issues which should be carefully managed in informed consent process by researchers? • In some countries, e.g. China, there are practices that REC members monitor some steps of the study (in cases of complicated or burden rich design of a study) on site.

  5. Adverse events • REC has crucial role to work with safety information (Costa Rica) • In several countries it is not the task of REC at all. • Researchers should present to REC with project application safety criteria to stop or continue project.

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